Biochemical Markers ,NGAL,Cystatin c, Acute Kidneyinjury, Covid 19NCT04603664
Role of NGAL and Cystatin C in Prediction of Acute Kidney Injury Covid-19 Infection
An observational study of Biochemical Markers ,NGAL,Cystatin c, Acute Kidneyinjury, Covid 19, run by Ain Shams University at 2 sites in Egypt.
Trial summary
Recent different biomarkers of acute kidney injury (AKI) have been manufactured by pharmaceutical industry. Studies proved that Neutrophil gelatinase-associated lipocalin (NGAL) and cystatin c are effective predictive biomarkers for early acute kidney injury in septic patients and in children after cardiopulmonary… Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Biochemical Markers ,NGAL,Cystatin c, Acute Kidneyinjury, Covid 19
- What is being tested?
- serum NGAL and cystatin c
- How many people
- 100 participants
- Where
- 2 sitesEgypt
- Study dates
- 30 Oct 2020to 30 Jun 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: adult patients from 18-85 diagnosed as covid 19 infection by nasaopharyngeal swap
Who may be able to join
- person with the one of the following symptoms: fever and respiratory symptoms with radiological findings of pneumonia compatible with COVID-19
- Respiratory distress (≥ 30 breaths/ min);
- Oxygen saturation ≤ 93% at rest;
- Arterial partial pressure of oxygen (PaO2)/ fraction of inspired oxygen (FIO2) ≤ 300.
- Cases with chest imaging that shows obvious lesion progression within 24-48 hours > 50%.
- Respiratory failure and requiring mechanical ventilation;
- Shock;
- other organ failure that requires ICU care.
Who cannot join
- patients classified as mild corona virsus disease, patients with end-stage renal disease (ESRD) or on chronic regular dialysis, presence of AKI and anuria at the time of ICU admission, history of chronic kidney disease, severe urinary tract infection, kidney malignancy, and renal transplantation.
Trial locations and contacts
2 sites in 1 country.
About this study
Official title: Role of Neutrophil Gelatinase-Associated Lipocalin (NGAL) and Cystatin C in Prediction of Acute Kidney Injury in Patients With Covid-19 Infection
Recent different biomarkers of acute kidney injury (AKI) have been manufactured by pharmaceutical industry. Studies proved that Neutrophil gelatinase-associated lipocalin (NGAL) and cystatin c are effective predictive biomarkers for early acute kidney injury in septic patients and in children after cardiopulmonary bypass. This study hypothesize that both cystatin c and Neutrophil gelatinase-associated lipocalin can predict AKI in patients with COVID-19 before elevation of serum urea and creatinine which may help early interference.
Read the detailed description
Since December 2019, a novel coronavirus called SARSCoV-2 (severe acute respiratory syndrome coronavirus 2) has caused an international outbreak of respiratory illness described as COVID-19. Among 85 patients with COVID-19 an incidence of acute kidney injury was reported to be 23%. The kidney histology from autopsies of six patients showed severe acute tubular necrosis with macrophage and lymphocyte infiltration. Another important paper revealed prominent acute proximal tubular injury, accumulation of peritubular erythrocyte and glomerular fibrin microthrombi after autopsy. However, this kidney injury was not detected by routine measures (creatinine and/or BUN) in some patients denoting subclinical kidney injury. The pathophysiology of AKI associated with COVID-19 could be due to specific mechanisms such as direct cell injury from viral entrance through highly expressed renal ACE2 receptors. Also pro-inflammatory cytokines, an imbalanced renin-angotensin-aldosterone system and thrombotic events are accused in renal damage. Non-specific mechanisms include hypovolemia, haemodynamic changes, right heart failure, high levels of PEEP in mechanically ventilated patients, nephrotoxic drugs and nosocomial infections. A significant association between kidney failure and death was documented in five studies. Hypoxemia and impairment of gas exchange has been identified as elements associated with AKI in patients with acute respiratory distress syndrome (ARDS).
Studies focusing on AKI with COVID-19 are needed urgently in order to identify the mechanism of renal affection and to predict the risk of AKI. Pharmaceutical industries with academia have made a lot of progress in the field of sensitive and specific preclinical biomarkers of kidney injury. Neutrophil gelatinase-associated lipocalin (NGAL) is composed of 178 amino acids. this glycoprotein is reabsorbed in the proximal tubules after its filtration through the glomeruli.
In a mouse model of renal ischemia, NGAL gene was rapidly expressed and upregulated within 3 hours of injury. The NGAL mRNA level increased more than 1000-fold 24-48 hours after injury. Thus, NGAL can be a useful tool to diagnose infection mediated AKI. Nonglycosylated Cystatin C is a protein produced by nucleated cells at constant rate. It is easily filtered through the glomeruli due to its positive charge at physiological pH and its low molecular weight. Then, it is reabsorbed and completely catabolized in the proximal tubules. Use of serum cystatin C as a marker of glomerular filtration rate (GFR) is well documented, and some authors have suggested that it may be more accurate than serum creatinine for this purpose. Complete evaluation of the clinical and laboratory picture of COVID-19 associated AKI is crucial to design preventive strategies and to suggest targeted interventions
- Being tested
- serum NGAL and cystatin c
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
serum NGAL and cystatin cDiagnostic test
measuring serum NGAL and cystatin c on admission and after 48 hours in critically ill patients with covid 19 then compare results to serum creatinine and signs of acute kidney injury
| Study group | Role | What they receive |
|---|---|---|
| study group | blood sampling and measduring of serum NGAL and cystatin c on admission and after 48 hours and creatinine every day Receives: Diagnostic Test: serum NGAL and cystatin c |
What is being measured
The primary outcome is the main question the study is designed to answer.
measure both cystatin c and Neutrophil gelatinase-associated lipocalin on admission and after 48 hours. (NGAL) as recent biomarkers in prediction of AKI in patients with COVID-19.
biochmical tests for detection of NGAL and Cystatin c in crirically ill Covid 19 patients
Measured: 12 days starting from hospital admission
Secondary outcomes (1)
development of acute kidney injury lipocalin (NGAL) to AKI severity and prognosis of AKI in patients with COVID-19 infection
increased serum creatinine
Measured: 12 days starting from day of admission
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2020
- Study start30 Oct 2020
- Primary completion30 Jun 2021
- Study completion30 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Biochemical Markers ,NGAL,Cystatin c, Acute Kidneyinjury, Covid 19Studies of the same condition, open and under way.
- More trials run by Ain Shams UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sanaa Farag Mahmoud Wasfy, Ain Shams University
- Investigators
- sanaa wasfy, Principal investigator, lecturer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04603664
- Sponsor's protocol ID
- FMASU P82b/2020
- Status last verified
- Sep 2021
- First submitted
- 17 Oct 2020
- Last updated
- 13 Sep 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Diao, C.H. Wang, R.S. Wang, Z.Q. Feng, Y.J. Tan, H.M. Wang, et al. ( 2020 ) Human kidney is a target for novel severe acute respiratory syndrome coronavirus 2[SARS-CoV-2] infection [preprint posted online April 10, . medRxiv doi:10.1101/2020.03.04.20031120 Xu S, Fu L, Fei J et al (2020) Acute kidney injury at early stage as a negative prognostic indicator of patients with COVID-19: a hospital-based retrospective analysis. medRxiv 2020.03.24.20042408. https://doi.org/10.1101/2020.03.24.20042408 Darmon M, Schortgen F, Leon R et al (2009) Impact of mild hypoxemia on renal function and renal resistive index during mechanical ventilation. Intensiv Care Med 35:1031-1038. https://doi.org/10.1007/s00134-008-1372-5 Darmon M, Schortgen F, Leon R et al (2009) Impact of mild hypoxemia on renal function and renal resistive index during mechanical ventilation. Intensiv Care Med 35:1031-1038. https://doi.org/10.1007/s00134-008-1372-5
Study at a glance
From the registry record, last updated by the sponsor on 13 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of Neutrophil Gelatinase-Associated Lipocalin (NGAL) and Cystatin C in Prediction of Acute Kidney Injury in Patients With Covid-19 Infection
- ClinicalTrials.gov ID
- NCT04603664
- Acronym / sponsor ID
- FMASU P82b/2020
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 30 Oct 2020 (actual)
- Primary completion
- 30 Jun 2021 (actual)
- Study completion
- 30 Jun 2021 (actual)
- First posted
- 27 Oct 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Recent different biomarkers of acute kidney injury (AKI) have been manufactured by pharmaceutical industry. Studies proved that Neutrophil gelatinase-associated lipocalin (NGAL) and cystatin c are effective predictive biomarkers for early acute kidney injury in septic patients and in children after cardiopulmonary bypass. This study hypothesize that both cystatin c and Neutrophil gelatinase-associated lipocalin can predict AKI in patients with COVID-19 before elevation of serum urea and creatinine which may help early interference.
Detailed description
Since December 2019, a novel coronavirus called SARSCoV-2 (severe acute respiratory syndrome coronavirus 2) has caused an international outbreak of respiratory illness described as COVID-19. Among 85 patients with COVID-19 an incidence of acute kidney injury was reported to be 23%. The kidney histology from autopsies of six patients showed severe acute tubular necrosis with macrophage and lymphocyte infiltration. Another important paper revealed prominent acute proximal tubular injury, accumulation of peritubular erythrocyte and glomerular fibrin microthrombi after autopsy. However, this kidney injury was not detected by routine measures (creatinine and/or BUN) in some patients denoting subclinical kidney injury. The pathophysiology of AKI associated with COVID-19 could be due to specific mechanisms such as direct cell injury from viral entrance through highly expressed renal ACE2 receptors. Also pro-inflammatory cytokines, an imbalanced renin-angotensin-aldosterone system and thrombotic events are accused in renal damage. Non-specific mechanisms include hypovolemia, haemodynamic changes, right heart failure, high levels of PEEP in mechanically ventilated patients, nephrotoxic drugs and nosocomial infections. A significant association between kidney failure and death was documented in five studies. Hypoxemia and impairment of gas exchange has been identified as elements associated with AKI in patients with acute respiratory distress syndrome (ARDS).
Studies focusing on AKI with COVID-19 are needed urgently in order to identify the mechanism of renal affection and to predict the risk of AKI. Pharmaceutical industries with academia have made a lot of progress in the field of sensitive and specific preclinical biomarkers of kidney injury. Neutrophil gelatinase-associated lipocalin (NGAL) is composed of 178 amino acids. this glycoprotein is reabsorbed in the proximal tubules after its filtration through the glomeruli.
In a mouse model of renal ischemia, NGAL gene was rapidly expressed and upregulated within 3 hours of injury. The NGAL mRNA level increased more than 1000-fold 24-48 hours after injury. Thus, NGAL can be a useful tool to diagnose infection mediated AKI. Nonglycosylated Cystatin C is a protein produced by nucleated cells at constant rate. It is easily filtered through the glomeruli due to its positive charge at physiological pH and its low molecular weight. Then, it is reabsorbed and completely catabolized in the proximal tubules. Use of serum cystatin C as a marker of glomerular filtration rate (GFR) is well documented, and some authors have suggested that it may be more accurate than serum creatinine for this purpose. Complete evaluation of the clinical and laboratory picture of COVID-19 associated AKI is crucial to design preventive strategies and to suggest targeted interventions
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| study group | – | Diagnostic Test: serum NGAL and cystatin cblood sampling and measduring of serum NGAL and cystatin c on admission and after 48 hours and creatinine every day |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- adult patients from 18-85 diagnosed as covid 19 infection by nasaopharyngeal swap
Key inclusion criteria (8 listed)
- person with the one of the following symptoms: fever and respiratory symptoms with radiological findings of pneumonia compatible with COVID-19
Key exclusion criteria (1 listed)
- patients classified as mild corona virsus disease, patients with end-stage renal disease (ESRD) or on chronic regular dialysis, presence of AKI and anuria at the time of ICU admission, history of chronic kidney disease, severe urinary tract infection, kidney malignancy, and renal transplantation.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| serum NGAL and cystatin cmeasuring serum NGAL and cystatin c on admission and after 48 hours in critically ill patients with covid 19 then compare results to serum creatinine and signs of acute kidney injury | Diagnostic test | study group |
Primary outcome
measure both cystatin c and Neutrophil gelatinase-associated lipocalin on admission and after 48 hours. (NGAL) as recent biomarkers in prediction of AKI in patients with COVID-19.
Time frame: 12 days starting from hospital admission
biochmical tests for detection of NGAL and Cystatin c in crirically ill Covid 19 patients
1 secondary outcome
development of acute kidney injury lipocalin (NGAL) to AKI severity and prognosis of AKI in patients with COVID-19 infection
Time frame: 12 days starting from day of admission
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Sep 2021.
- BackgroundDiao, C.H. Wang, R.S. Wang, Z.Q. Feng, Y.J. Tan, H.M. Wang, et al. ( 2020 ) Human kidney is a target for novel severe acute respiratory syndrome coronavirus 2[SARS-CoV-2] infection [preprint posted online April 10, . medRxiv doi:10.1101/2020.03.04.20031120 Xu S, Fu L, Fei J et al (2020) Acute kidney injury at early stage as a negative prognostic indicator of patients with COVID-19: a hospital-based retrospective analysis. medRxiv 2020.03.24.20042408. https://doi.org/10.1101/2020.03.24.20042408 Darmon M, Schortgen F, Leon R et al (2009) Impact of mild hypoxemia on renal function and renal resistive index during mechanical ventilation. Intensiv Care Med 35:1031-1038. https://doi.org/10.1007/s00134-008-1372-5 Darmon M, Schortgen F, Leon R et al (2009) Impact of mild hypoxemia on renal function and renal resistive index during mechanical ventilation. Intensiv Care Med 35:1031-1038. https://doi.org/10.1007/s00134-008-1372-5
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
sanaa wasfy principal investigator
lecturer
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Biochemical Markers ,NGAL,Cystatin c, Acute Kidneyinjury, Covid 19, run by Ain Shams University at 2 sites in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
measure both cystatin c and Neutrophil gelatinase-associated lipocalin on admission and after 48 hours. (NGAL) as recent biomarkers in prediction of AKI in patients with COVID-19. (time frame: 12 days starting from hospital admission). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04603664, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Sep 2021.